Request for Applications: “Veterinary Translational Medicine - Animal Models of Human Disease”
Supported by a Collaborative Research Program involving the University of Minnesota,
Indiana University, Purdue University, and the Eli Lilly Corporation
Background : Veterinary translational medicine is the discipline by which the confidence of new therapeutic treatments for specific disease states in human patients is increased through the use of relevant, spontaneous veterinary disease models. Veterinary translational medicine offers several unique advantages in drug development. The high rate of compound failure in human clinical trials is due, in part, to poor pre-clinical predictors, and increasingly costly clinical trials have resulted in fewer successful drugs reaching the market.
Contrived rodent models do not always translate into human health or disease. Natural disease states in veterinary patients offer a more realistic approach to studying therapies for relevant diseases in humans and may better reflect the underlying heterogeneity of clinical disease. Chronic diseases are more readily studied in a canine model, for example, because their disease progression occurs in a narrower time frame than the same human disorder. Veterinary translational studies can inform human health studies at several stages. They can inform at the lead development stage to increase confidence in measures used to optimize potential drug candidates. They can also inform after candidate nomination, in parallel with healthy volunteer studies to build confidence in an investment trajectory for patient studies, particularly those requiring long treatment durations and/or large patient exposures. And, they can inform by increasing confidence in safety, particularly around mechanisms that are relevant to the disease condition in humans and animals.
Funding Opportunity : The University of Minnesota, Indiana University, Purdue University, and Eli Lilly
Corporation have entered into a collaborative research agreement to support veterinary translational medicine studies of animal models of human disease. We are soliciting proposals for innovative research projects that advance translational therapies for human and veterinary species.
Research Criteria :
(1) A clinical disorder in companion animals for which there is a fundamental biology and pathobiology;
(2) The pathophysiology, biochemistry, immunology, and genetics are similar if not identical to the human condition;
(3) Research program and track record exists at both institutions (University of Minnesota and Purdue
University);
(4) Clinical caseload is sufficient for study at both institutions (Minnesota and Purdue);
(5) Emphasis on the translational research component of the basic-clinical-translational research continuum;
(6) Collaborative research proposal from both institutions - one co-Principal Investigator from each site;
(7) Evidence of clinical case coordination and recruitment - Clinical Investigation Center (UMN) and Clinical
Trials Group(Purdue);
(8) Projects that are novel and innovative in their approach and methodology;
(9) Clear clinical translational pathway upon successful completion of the work that can be conducted at both
IUPUI and UMN;
(10) Assurances that a potential clinical trial can be conducted at IUPUI and UMN if the preclinical outcome data warrant further study;
(11) Potential to obtain future competitive extramural funding.
Program Emphases : Research proposals that are translationally-oriented, collaborative across institutions, with evidence of future applicability to human clinical trials, and with high probability of future federal funding will be reviewed more competitively. Preference will be given to proposals that can be translated in the appropriate human settings within 3-4 years at IUPUI and UMN following project funding. Additional preference will be given to projects that utilize approaches or reagents developed at Eli Lilly that can be tested in these animal models and in the clinic. It is the intent of this RFA to foster collaborations between IUPUI, UMN, and Eli Lilly investigators to the greatest extent possible in preclinical modeling and translational medicine, including future clinical trials funded under other auspices. Project teams will be formed involving all four partners to facilitate the design of preclinical studies most readily translatable into clinical studies at both sites. Studies will be implemented at the respective Clinical Investigation Centers. It is expected that such studies will lead to

publication(s) that include representation from these research teams as well as downstream participation in clinical trial development and translation.
Funding : Total funding available is $450,000 per year and we anticipate that 3 or 4 proposals will be funded per year. Projects may be one-two years with second half of funding subject to satisfactory progress in the first half of the project period. Projects will be awarded and funding will begin on June 1, 2010.
Proposal Guidelines:
A. Descriptive Abstract (≤250 words) and list of Investigators
B. Background, Significance and Preliminary Data (if available): Provide sufficient background, including justification of the problem and rationale for the approach.
C. Strategic Positioning: Describe how the proposed project will advance translational medicine and eventual treatment of human disorders. Also describe the possible pathway toward translational applications in terms of a potential trial design, including statements that ensure adequate numbers of patients will be available for future human clinical trials that arise from these studies.
D. Integrative Approach: Briefly describe the unique skills of the team, how the project will involve the Clinical
Investigation Center (Minnesota) and Clinical Discovery Laboratory (Purdue), how the team will work together, and how the new partnership will strengthen and expand Comparative Medicine and Animal Models of Human
Disease.
E. Research Work Plan.
F. Potential Impact: Include details on how this project will support a future competitive application for federal funding (e.g., NIH, NSF). Note potential impact on animal and human health as well as unique advantages compared to other animal models.
G. Funding Plan: Describe existing leveraged funding and plans for future funding.
H. Cited literature.
I. Biographical sketches: Provide a 4-page NIH biosketch for each team member.
J. Categorical budget (include all personnel and detailed categories for supplies, reagents, animal care, etc.)
K. Assurances: provide information regarding submission or approval to institutional IACUCs, and IBC (if recombinant DNA technology or biohazardous materials are involved). All participating personnel are required to have current training in laboratory and chemical safety.
The main proposal text (sections A-G) must not exceed 10 pages single-spaced (1-inch margins, 11-point Arial font).
Review Panel : The Review Panel will be constituted of two members from each of the partnering institutions
(University of Minnesota, Indiana University, Purdue University, Eli Lilly Corporation).
PROPOSAL DEADLINE: May 3, 2010.
AWARD NOTIFICATION DATE: May 14, 2010
FUNDING AVAILABILITY: June 1, 2010
Submit the research proposal electronically as one document in PDF format to washabau@umn.edu

PROJECT OUTLINE
1. Project Title (100-character maximum, including spaces)
2. Principal Investigator(s)/Project Director(s) a. PI/PD Name (first, last) Department/College
________________________________________________________________________ b. Co-PI Name (first, last) Department/College
________________________________________________________________________ c. Co-PI Name (first, last) Department/College
________________________________________________________________________ d. Co-PI Name (first, last) Department/College
________________________________________________________________________
3. Period of proposed project From: Through:
4. Funds requested ______________________________
Signature of Principal Investigator(s)/Project Director(s) (All listed in No. 2 must sign)
__________________________________________________________Date _______________
Signature of Department Chairs (if more than one department involved, all must sign)
__________________________________________________________Date _______________